A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab
Alexion Pharmaceuticals, Inc. · NCT07221838
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 4
- Target enrollment
- 75
- US sites recruiting
- 1
- Study start
- March 4, 2026
- Record last updated
- April 9, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
This is a prospective, multicenter single arm study designed to evaluate the effectiveness and safety of a predefined oral corticosteroids (OCS) tapering schedule to reduce OCS use in adult participants with acetylcholine receptor positive (AChR+) generalized myasthenia gravis (gMG) being treated with intravenous ravulizumab.
Being studied: Oral Corticosteroid Tapering Schedule; Ravulizumab; Prednisone/Prednisolone
Conditions: Generalized Myasthenia Gravis; gMG
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Aged greater than 18 years and male or female
- Clinical diagnosis of gMG
- Receiving ravulizumab treatment prior to enrollment
- Receipt of OCS therapy equivalent to a daily dose ≥ 7.5 mg of prednisone/prednisolone for ≥ 4 continuous weeks directly preceding enrollment
- A participant of childbearing potential must have a negative highly sensitive pregnancy test (serum or urine, as required by local regulations) taken at Screening before OCS tapering begins.
- Willing to sign informed consent
Exclusion Criteria
- Concurrent participation in an interventional clinical trial.
- History of chronic hypoadrenalism (ie, Addison's disease).
- Use of concomitant OCS for comorbid conditions other than gMG
- Receipt of a biologic for gMG (e.g., efgartigimod, rozanolixizumab, inebilizumab, rituximab, intravenous immunoglobulin) within 5 half-lives of enrollment
- Pregnant, breastfeeding, or intending to conceive during the course of the study
Recruiting US locations
Research Site
Raleigh, NC 27607
Study contacts (from the official record)
- Alexion Pharmaceuticals, Inc. (Sponsor) · 1-855-752-2356 · clinicaltrials@alexion.com